尼非卡兰和胺碘酮治疗急性心肌梗死新发房颤有效性和安全性对比研究

Comparison of nifekalant and amiodarone in the treatment of new-onset atrial fibrillation in acute myocardial infarction patients

目的:探讨尼非卡兰和胺碘酮治疗急性心肌梗死新发房颤的有效性和安全性。方法:纳入泰达国际心血管病医院重症监护室2017年1月-2018年5月收治的急性心肌梗死合并新发房颤的患者共106例,按计算机产生的随机序号分为尼非卡兰组52例和胺碘酮组54例,分别予尼非卡兰(注射用盐酸尼非卡兰,50 mg):负荷剂量:0.3 mg/kg输注5 min,维持剂量:0.4 mg/kg/h;胺碘酮(盐酸胺碘酮注射液,可达龙,3 mL:0.15 g):负荷剂量:15 mg/min输注10 min,维持剂量:1 mg/min治疗,观察2组患者24 h房颤转复率及控制率,治疗前后血压、心率、左心室射血分数、不良反应等。结果:尼非卡兰组和胺碘酮组的房颤转复率分别为50(96%)、42(78%),具有统计学差异(P=0.001)。尼非卡兰组转复时间较短(2.7±1.3,P=0.02),24 h房颤发作控制率未见明显统计学差异(P=0.16),但尼非卡兰组相对比例较高(77%)。尼非卡兰组对收缩压(P=0.24)、舒张压(P=0.32)、心率(P=0.23)未见明显影响,可升高LVEF(P=0.001)、延长QTc(P=0.001)。不良反应方面,尼非卡兰组发生率低,仅1例尖端扭转室速,停药后恢复,总体不良反应发生率与胺碘酮组无明显统计学差异(P=0.27)。结论:尼非卡兰对急性心肌梗死新发房颤的治疗效果显著,对血压心率影响小,不良反应发生率低。

Objective: To compare nifekalant and amiodarone in the treatment of new-onset atrial fibrillation in acute myocardial infarction patients. Methods:Patients admitted to TEDA International Cardiovascular Hospital from January 2017 to May 2018 with acute myocardial infarction and new-onset atrial fibrillation were randomized into 52 patients in the nifekalant group and 54 patients in amiodarone group according to random numbers produced by computer. Those two groups were treated with nifekalant(loading dose: 0.3 mg/kg infusion for 5 minutes;maintenance dose: 0.4 mg/kg/h) and amiodarone(loading dose: 15 mg/min infusion for 10 minutes;maintenance dose: after 1 mg/min treatment).The 24-hour recovery rate and control rate of atrial fibrillation in the two groups were observed, and blood pressure, heart rate, left ventricular ejection fraction, and adverse reactions before and after treatment were measured. Results: A total of 106 patients with acute myocardial infarction complicated with new-onset atrial fibrillation were enrolled in this study. The rates of atrial fibrillation reversal in the nifekalant and amiodarone groups were 50(96%)and 42(78%)respectively, with statistical significance (P=0.001). The time of conversion was shorter in the nifekalant group(2.7±1.3, P=0.02), and the control rate of atrial fibrillation at 24 hours was not significantly different(P=0.16), but the relative proportion was higher in the nifekalant group(77%). The nifekalant group had no significant effect on systolic blood pressure (P=0.24), diastolic blood pressure (P=0.32), and heart rate (P=0.23), and increased LVEF(P=0.001)and prolonged QTc(P=0.001). Adverse reactions caused by nifekalant was low, and there was no significant difference between those two groups (P=0.27). Conclusion:Nifekalant has a significant effect on the treatment of new-onset atrial fibrillation in patients with acute myocardial infarction. It has little effect on the blood pressure and heart rate and the incidence of adverse reactions is low.